Insulin is a hormone that is central to regulating carbohydrate and fat metabolism in the body. Aberrant levels of insulin indicate glycemic disorders and/or insulin resistant syndromes such as diabetes. Diabetes and its complications represent a major public health issue. Thus, quantitation of insulin in diabetic and pre-diabetic patients is important both as a diagnostic tool and for monitoring treatment in patients.
Immunological techniques have been widely used for insulin quantitation, initially through radioimmunoassay (RIA), and more recently by commercially available immunochemiluminometric assays (ICMA) on automated platforms. However, no international reference method for insulin has yet been established. The major hurdle in establishing such a method stems from the variability in insulin values measured across different immunoassays and platforms, which are likely caused by differing cross-reactivities of the assay antibodies utilized.
A reliable and accurate method for measuring insulin levels is needed.